Chronic Migraine Epidemiology and Outcomes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01648530
First received: July 20, 2012
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

This is a population internet-based study to characterize migraine clinical course and impact on family.


Condition Intervention
Migraine Disorders
Other: No Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.

  • Migraine Disability Assessment (MIDAS) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.


Enrollment: 16789
Study Start Date: July 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Migraines
Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
Other: No Treatment
No Treatment

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with migraine

Criteria

Inclusion Criteria:

  • History of migraine
  • U.S. Member of Survey Panel
  • Household member of study participant
  • Ability to complete internet-based questionnaires

Exclusion Criteria:

  • No access to internet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648530

Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01648530     History of Changes
Other Study ID Numbers: GMA-BTX-12-470
Study First Received: July 20, 2012
Results First Received: January 21, 2015
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on May 26, 2015